First Covid vaccine for children aged from just SIX MONTHS could be available by the end of February

The first Covid-19 vaccine for children aged from just six months to five years old could be available as soon as the end of February, according to reports.

U.S. regulators are urging drugmaker Pfizer to apply for emergency authorization for a two-dose regimen of its COVID-19 vaccine for children in the age group, a person familiar with the matter told the Washington Post on Monday.

Officials are aiming to to clear the way for the shots to be used as soon as late February, the source said.

Meanwhile, regulators are also awaiting data on a three-dose course that they hope will prove more effective for children, the Associated Press has reported. 

The company’s application was expected to be submitted as soon as Tuesday. 

However, research shows that Covid poses a very low risk to babies and toddlers, and previous decisions to offer vaccines to children have caused controversy.

Centers for Disease Control and Prevention (CDC) data shows as of January 22, there have been 280 deaths involving Covid among children aged between zero and four years old. That number rises to 603 for those aged from five to 18 years old.

Combined, deaths involving Covid among those 18-and-under make up around 0.102 percent of America’s 864,256 total deaths, as of January 22.

If approved, the U.S. would become one of the only countries in the world to begin vaccinating young children as young as six months, with Cuba being the only other known country vaccinating children as young as two years old. 

‘The idea is, let’s go ahead and start the review of two doses,’ the Washington Post report quoted one of the people familiar with the situation as saying. 

‘If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.’ 

Pfizer said in January it expected the latest results from a clinical trial for kids under the age of 5 by April, after it amended its study to give a third dose to everybody who’s less than five at least eight weeks after their last vaccination. 

Early Pfizer data has shown the vaccine – which is administered to younger children at one-tenth the strength of the adult shot – is safe and produces an immune response.

But last year Pfizer announced the two-dose shot proved to be less effective at preventing COVID-19 in kids ages two to five.

Regulators encouraged the company to add a third dose to the study on the belief that another dose would boost the vaccine’s effectiveness much like booster doses do in adults.

Now, the Food and Drug Administration is pushing the company to submit its application based on the two-dose data for potential approval in February, and then to return for additional authorization once it has the data from the third dose study, which is expected in March, the person familiar with the matter said. 

The two-step authorization process could mean that young children could be vaccinated more than a month earlier than previous estimates, assuming the FDA and the Centers for Disease Control and Prevention greenlight the shots.

The person spoke to the Associated Press on the condition of anonymity to discuss sensitive regulatory issues. 

They said the decreased effectiveness of the two-dose vaccine was not unexpected given the emergence of the highly transmissible omicron variant of COVID-19. 

Allowing young kids to be vaccinated with a two-dose shot earlier would ultimately accelerate when they could get the expected stronger protection from a third dose.

That would be welcome news for parents of young children, the last remaining age group without approval of COVID-19 shots.

Young children are far less likely than adults to develop serious complications or to die from COVID-19, but incidences of illness among the age group have risen amid the nationwide spike in cases from the omicron variant. 

Most cases and deaths occur among older people, especially those who are unvaccinated.

However, last month it was reported that a record number of children under the age of five were hospitalised with Covid-19, specifically the Omircon variant.

According to NBC News, a new symptom was being seen among the age group – a harsh ‘barking’ cough known as croup. While experts say the cough is not harmful, the noise of the cough can be alarming for parents of young children.

Speeding the authorization of pediatric vaccines against COVID-19 has been a priority for more than a year of the Biden administration, which believes them critical to reopening and keeping open schools and day care centers – and for freeing up parents occupied by childcare responsibilities to return to the workforce.

Vaccines for kids ages 5-12 were approved by U.S. regulators in November, though uptake of shots has been slower than U.S. officials hoped.

Pfizer’s primary series is administered three weeks apart. The third dose for young kids is being studied for administration at least two months after the second dose.

So far, the only country worldwide known to be vaccinating children as young as two years old is Cuba, which has given doses to 95 percent of two-to-18-year-olds. 

Trust in the public health service in the island nation is high, with the country deploying its own homemade vaccines, such as Abdala.

Dr Gerardo Guillén, the lead developer of the vaccine, told The Guardian that the risk of Covid-19 among children is low, but vaccinating them will reduce transmission. 

‘Although Covid hits children less severely, they are an important factor in transmission,’ he told the newspaper. 

Some Chinese provinces are reported to have begun vaccinating children as young as three, with two Sinopharm and one Sinovac vaccines approved for those who are three-years-old and above. 

However, other countries have rejected vaccinating children. Just last week, Sweden’s health agency refused to approve vaccines from children under the age of 11, saying that there were no ‘clear benefits’ to justify vaccinating children.

Dr Jon K Andrus, a professor of public health at George Washington University, told The Guardian that he remained wary about seeing young children vaccinated in Cuba. ‘None of the results have been published in peer-reviewed journals, so it’s hard to discuss,’ he said.

Dr Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Texas, told the newspaper that while the need for children to be vaccinated was ‘essential’ to public health, caution must be taken.

‘The vaccine ecosystem is fragile. If you get it wrong, especially with someone’s child, it can have spillover effects and derail other vaccine programmes,’ he said.